Midazolam Hydrochloride Injection Shortage: Current Availability and Manufacturer Updates

Source: FDA · United States

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The FDA reports a current shortage of Midazolam Hydrochloride Injection, a medication used in anesthesia and neurology, with varying availability across multiple manufacturers.

What this FDA drug-shortage notice tells you, and what most readers miss

This notice was issued by FDA on February 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Drug Shortages — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA drug-shortage notice is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (drug-shortage, fda, medication, Midazolam) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What's in Shortage

Midazolam Hydrochloride Injection is currently listed in shortage. This medication, which falls under the therapeutic categories of Anesthesia and Neurology, is available under the brand names MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, and MIDAZOLAM IN SODIUM CHLORIDE. The shortage affects various presentations of the injection dosage form. This status was first posted on April 2, 2020, and was most recently updated on February 5, 2026.

Which Manufacturers Are Affected

Several manufacturers are involved in the supply of Midazolam Hydrochloride Injection, with varying levels of availability:

  • Fresenius Kabi USA, LLC (Contact: 888-386-1300)

    • Available: 1 mg/1 mL (NDC 63323-411-12 and 63323-411-25), 5 mg/1 mL (NDC 63323-412-25 and 63323-412-02), and Preservative Free 2 mg/2 mL (NDC 76045-211-20). The manufacturer advises checking wholesalers for inventory.
    • Unavailable: 1 mg/1 mL (NDC 63323-411-10) and 5 mg/1 mL (NDC 63323-412-10).
  • Avet Pharmaceuticals, Inc. (Contact: 855-228-9470)

    • Available: 1 mg/1 mL (NDC 23155-600-41) and 5 mg/1 mL (NDC 23155-601-42).
    • Unavailable: 5 mg/1 mL (NDC 23155-601-41). The estimated recovery date for this presentation is February 11, 2026.
  • WG Critical Care (Contact: 888-493-0861)

    • Available: Midazolam in 0.9% Sodium Chloride, 1 mg/1 mL (NDC 44567-611-10 and 44567-610-10). Patients and providers are encouraged to check wholesalers and distributors for inventory.

Why There's a Shortage

The source data does not provide a specific reason for the current shortage of Midazolam Hydrochloride Injection.

What Patients Should Do

Patients who require Midazolam Hydrochloride Injection should be aware that while some presentations are unavailable, others remain in supply. If you are concerned about how this shortage may affect your care, please take the following steps:

  • Consult your healthcare provider: Discuss your treatment plan and any concerns regarding medication availability.
  • Speak with your pharmacist: They can provide the most current information on local stock and wholesaler availability.
  • Contact manufacturers: You may use the contact information provided above to inquire about specific product availability.

Disclaimer: Patients should always consult with their healthcare provider regarding medical advice, diagnosis, or treatment.

Source

Information provided by the FDA Drug Shortage Database.

Original source: FDA Official Notice ↗

All Drug Shortages →

Frequently Asked Questions

Common questions about this FDA drug-shortage notice.

What is this FDA drug-shortage notice about?
The FDA reports a current shortage of Midazolam Hydrochloride Injection, a medication used in anesthesia and neurology, with varying availability across multiple manufacturers.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more Drug Shortages updates?
Browse the full Drug Shortages feed on Areazine at areazine.com/drug-shortages/ for the latest updates from FDA and other agencies.